title: A combined analysis of five observational studies evaluating the efficacy and tolerability of bimatoprost/timolol fixed combination in patients with primary open-angle glaucoma or ocular hypertension.
abstract: OBJECTIVE
  The aim of this study was to evaluate the safety and efficacy of a fixed combination of bimatoprost 0.03% and timolol (BTFC) in a clinical setting, in a large sample of patients with primary open-angle glaucoma or ocular hypertension and insufficient intraocular pressure (IOP) lowering on prior therapy.
  
  
  METHODS
  Patient data were combined (n = 5556) from five multicenter, observational, non-controlled, open-label studies throughout Europe. Patients were identified from 830 sites in Austria, France, Germany, The Netherlands, and Switzerland. Assessments were made at baseline, 6 weeks (in Austrian, German and Swiss centers), and 12 weeks in all centers.
  
  
  RESULTS
  BTFC lowered mean IOP from baseline by 5.4 mmHg over the 12-week duration of the studies (P < 0.0001). At study entry, 92.9% of patients were receiving another ocular hypotensive medication. In patients with no previous treatment (n = 311), BTFC reduced IOP by -9.1 mmHg, corresponding to a reduction from baseline of 36.4% (P < 0.0001). In patients receiving prior therapy of a prostaglandin analog, a β-blocker, or a fixed combination, BTFC reduced IOP by a further 24.5%, 25.9%, and 21.4%, respectively. The majority of patients (90.3%) reported no adverse events. The most common adverse events were conjunctival hyperemia (3.2%) and eye irritation (2.8%). BTFC was rated as "good" or "very good" by 92.5% of physicians and 88.0% of patients. Most patients (96.3%) were equally or more compliant with BTFC than with their previous treatment.
  
  
  CONCLUSIONS
  In routine clinical practice, BTFC achieved consistent IOP lowering in both previously treated and untreated patients with primary open-angle glaucoma or ocular hypertension. BTFC was associated with significant IOP reductions, good tolerability, and good compliance.
authors.affiliation: Ophthalmology Practice, Polch, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Pfennigsdorf
authors.forename: Leo
authors.initials: L
authors.lastname: de Jong
authors.forename: Stefan
authors.initials: S
authors.lastname: Makk
authors.forename: Yvette
authors.initials: Y
authors.lastname: Fournichot
authors.forename: Alain
authors.initials: A
authors.lastname: Bron
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Morgan-Warren
authors.forename: John
authors.initials: J
authors.lastname: Maltman
keywords: bimatoprost 0.03%; intraocular pressure; ocular hypotensive medication; prostaglandin analog; β-blocker